asked the Minister for Health if he will indicate whether he intends to take any steps to protect the consumer in relation to importation into Ireland from the US of human and veterinary drugs which have not been approved for sale in the US; if his attention has been drawn to the concerns of the International Organisation of Consumer Associations on this matter; and if he will make a statement on the matter.
Written Answers. - Importation of Drugs.
10.
Comprehensive controls already exist to protect the consumer in relation to the importation and placing on the market in this country of all human and veterinary drugs. These controls are identical to those in operation in all other member states of the EC and are implemented in pursuance of a number of EC directives relating to medicinal products for human or veterinary use.
These controls are implemented mainly by means of product authorisation schemes which require that persons wishing to import and place medical or veterinary preparations on the market in this country must first obtain an authorisation in respect of each preparation. A special licence is required also in respect of the importation of therapeutic substances such as vaccines. Furthermore, persons importing medical or veterinary preparations from the US or from any other non-EC country must obtain a manufacturing licence from my Department in respect of such preparations.
I am aware of the concern expressed by the International Organisation of Consumer Unions in this matter. However, having regard to the controls in force in this country I do not consider that the Irish consumer should have any concerns in this regard.